Back to search
Description:
Conduct supplier evaluation and risk assessments including on-site quality audits as required to ensure conformance to Supplier Quality System requirements.
Analyze audit results to develop, prioritize and execute corrective actions and supplier development action plans to continually improve supplier performance.
Lead supplier quality activities that will improve quality of the product and process as measured by internal quality metrics and external quality indicators.
Provide supplier quality support on NPD and incoming purchased finished goods initiatives.
Provide support in establishing and implementing standardized quality best practices, processes, procedures within the supply chain and across suppliers.
Work closely with Suppliers and internal resources to maintain and update supplier performance evaluations, supplier audit procedures and policies, approved supplier listing and supplier risk assessments.
Oversee inspection of incoming components, finished goods and products from suppliers and manufacturers.
Conduct periodic material evaluations.
Work to identify and resolve potential problems and continually improve process for qualification and evaluation of new and existing suppliers, specifications, components, and materials.
Collaborate with purchasing, manufacturing, quality and R&D to improve overall product quality by emphasizing defect prevention throughout the supplier management process.
Identify and communicate to Quality leadership issues that impact product quality, safety or efficacy, regulatory compliance or business continuity which have arisen from a supplier.
Ensure closure of NC’s and CAPA’s, to confirm comprehension, development, and execution of corrective/preventive action with regards to any nonconformity cited.
Act as the key interface with site operations as it pertains to Supplier Quality Issues.
Identify areas of opportunity and support continual improvement of product quality.
Perform other duties as assigned
Lead quality review for scale up, pilot and stability batch production, including record review and approval during the development process.
Ensure accurate and timely development of test criteria, product specifications.
Assist R&D and Operations with the interpretation of Quality requirements, including verification/validation planning and execution, scale-up activities, first or pilot production run requirements and problem resolution.
Skills:
FDA, GMP, Supplier Quality, Quality Systems
Additional Skills & Qualifications:
Bachelor Degree
3-5 years experience in a regulated environment
2 years experience in supplier interfacing role
Knowledge of cGMP Guidelines and regulatory requirements.
Strong time management/project management capabilities
Working knowledge of Process / Manufacturing applications
Ability to manage multiple projects simultaneously while meeting project milestones and timelines
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
